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Completed

NCT Number: NCT03275259

Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body contour,decrease fat localized and appearance of gynoid lipodystrophy.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.

HYPOTHESES: It is expected that the patients will present improvement in the body contour, decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p <0.05.

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Key information

Conditions

Lipodystrophy Adiposity Body Weight Cellulitis Connective Tissue Diseases Infections Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Diseases, Metabolic Skin and Connective Tissue Diseases Suppuration

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, 13901-080, Brazil

About this study

After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be personal data, anthropometrics and complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started treatment with another physiotherapist who will perform the following study protocol: placing a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens, buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks, posterior thigh emil shots in the region of flanks. The protocol will be performed twice a week for 1 and 20 hours each, totaling 10 sessions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women older than 18 years of age up to premenopausal age (50 years of age).
  • With body mass index considered eutrophic and / or overweight.
  • Patients with lipodystrophy and localized abdominal fat.
  • non smokers.
  • Who agree to participate and sign the informed consent form.

Exclusion criteria

  • Male gender.
  • Possible.
  • Haemophilia carriers and hemorrhagic disorders.
  • Carriers diabetes mellitus.
  • Women in menopause.
  • Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last 1 months.
  • Patients with skin lesions, such as dermatitis and dermatoses.
  • Patients with acute deep vein thrombosis (DVT).
  • About or close to cancerous lesions.
  • Patients with cardiac pacemaker or other implanted electronic device.

Treatment and study plan

THORK Shock Wave® (Extracorporeal shock waves)

Device

Treatment with extracorporeal shock waves: energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.

Primary outcomes

  1. Anthropometric evaluation

    Time frame: Ten minutes

    BMI (kg / height m2)

  2. Anthropometric evaluation

    Time frame: Ten Minutes

    Perimeter in the region to be treated in centimeters.

  3. Evaluation of the degree of cellulite

    Time frame: Ten minutes

    Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.

  4. Assessment of adipose tissue thickness

    Time frame: Twenty minutes

    Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)

  5. Assessment of skin elasticity

    Time frame: Twenty minutes

    Evaluation of skin elasticity (Cutometer® MPA580)

Sponsors and collaborators

Lead sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED

Industry

Registry information

Official study title

Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat

Acronym: ESWT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2017
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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